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FDA 510(k) Application Details - K980482
Device Classification Name
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510(K) Number
K980482
Device Name
TRIANGLE SLING
Applicant
INFLUENCE, INC.
11812 QUINCE MILL DR.
NORTH POTOMAC, MD 20878 US
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MARK D KRAMER
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Regulation Number
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Classification Product Code
OTN
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Date Received
02/09/1998
Decision Date
03/27/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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